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Using Electronic Health Record Systems to Promote Patient Safety in the Use of Biologics and Biosimilars

The rapid expansion of biologics and the recent introduction of biosimilars to the US healthcare market represents an exciting public health opportunity, as well as an obligation to increase patient safety through better tracking of biologic use for improved adverse event reporting and outcomes research.

Made from living organisms, biologics hold great promise for providing a lower cost treatment option for chronic diseases such as arthritis, diabetes and cancer. Patents will soon expire on biologic products used to treat many chronic diseases for which biosimilars may be introduced. For example, 12 biological products with global sales of more than $67 billion will be exposed to biosimilar competition by 2020. As more biosimilars are approved and enter the market, however, it will become increasingly challenging and important to accurately identify and distinguish the source of the adverse events (AEs) from a biosimilar, its reference biologic, and other biosimilars.

The article below from Pooja Babbrah examines an important patient safety consideration for biosimlars: how to indicate to the prescriber that a substitution has been made either for a biosimilar over another drug or one biosimilar over another.

Biosimilars are starting to enter the market in the United States and are expected to quickly become mainstream in the near future because of their significant cost-savings and patient care implications. There are a number of issues the industry must address as biosimilars become more widespread. One that requires high-priority attention is how to indicate to the prescriber that a substitution has been made either for a biosimilar over another drug or one biosimilar over another. Why is this important? Patient safety is at stake.

This issue is taking on heightened importance now that nearly two-thirds of states have enacted — or are considering enacting — legislation requiring that physicians be notified when a biosimilar substitution is made. Biosimilars are made from living organisms and are different in chemical composition than conventional medications. They vary in how and where they are administered — most are infused in hospitals, special ambulatory centers and even patients’ homes. The physician must have information about which specific product was dispensed to a patient to ensure care quality and to protect the patient’s safety in case an adverse event occurs. Despite legislative efforts to ensure that the provider is notified of the substitution, such legislation is silent as to how such notification should be done.

There are four possible electronic transactions that could be used to indicate to a prescriber that a substitution was made and which biosimilar was dispensed. These transactions are used by electronic health record (EHR) systems to communicate between prescribers and pharmacies. NCPDP SCRIPT standard contains three transactions that might be used to indicate a biosimilar substitution: RxFill, RxChange and medication history. The fourth possibility is consultation with state prescription drug monitoring programs (PDMPs), which are state-specific databases containing information about dispensed controlled substances.

What are the pros and cons of each? Is there one best option? Let’s take a look.

RxFill or fill status notification. This transaction is sent to the prescriber from the pharmacy and indicates the status of the prescription (dispensed, partially dispensed or not dispensed).

Pros: This transaction is part of the suite of NCPDP electronic prescribing (ePrescribing) transactions. It is specially designed to alert prescribers when a medication was dispensed. The RxFill standard was modified in 2015 to accommodate biosimilars by the addition of an optional field for lot number. It also can indicate whether a prescription has been filled, partially filled or not filled. Fill status can help the physician monitor medication adherence — a care quality issue for all drugs but a patient safety issue for biosimilars if it becomes necessary to determine why an adverse event occurred.

Cons: The RxFill transaction is not widely utilized by pharmacy and EHR systems, although user demand may push that change in the near future.

RxChange. This transaction is sent by the pharmacy to the prescriber when the pharmacy would request approval to switch from a drug originally prescribed to something different. RxChange would typically be utilized in situations in which an insurer has a preferred alternative drug, if the drug is not covered by the patient’s insurer or if a quantity change from a 30- to 90-day supply has been requested. RxChange is a bidirectional transaction, involving a query from the pharmacy and a response by the prescriber.

Pros: This transaction is part of the suite of NCPDP ePrescribing transactions.

Cons: This transaction was not designed for pharmacy-to-prescriber notifications. It is a query-response transaction and would be adapted to use only the query portion to notify the prescriber of a biosimilar substitution. This does not fit in with pharmacy work flows, as the pharmacy system would be waiting for the response to be sent by the prescriber. RxChange is not widely utilized by EHRs and pharmacy systems.

Medication history. This NCPDP SCRIPT query transaction is sent from a doctor to an intermediary (such as Surescripts), which in turn requests a patient’s medication history from various payers. The intermediary gathers the responses, which are then downloaded into a patient’s medication history file in the EHR.

Pros: This is part of the suite of ePrescribing standards. Responses give the provider a wide range of information about what was prescribed, where the prescription was filled and whether it was covered by insurance. Medication history is widely utilized by EHRs and pharmacy systems.

Cons: Medication history requests are typically made when a patient visit is scheduled. Data latency is an issue because of the time lapse between patient visits, when the prescription information is downloaded. This means that each dispense of a biosimilar may not be included in the medication history if multiple dispenses were made between visits.

PDMPs. Prescription drug monitoring programs are state-run databases that contain information about all controlled substance prescriptions dispensed in each state (except Missouri, which lacks a PDMP). The information is supplied by pharmacies on varying timetables (such as daily, weekly or monthly). Most states encourage prescribers to check the database before prescribing a controlled substance to help address the epidemic problems of prescription drug overdose and doctor shopping. New York mandates checking with the PDMP for nearly all controlled substance prescriptions and other states are expected to follow its lead. PDMP content, technical aspects and accessibility (such as who has access to the database and for what purpose) vary by state.

Pros: PDMPs will capture details about biosimilar prescribing and substitution for biosimilars classified as controlled substances.

Cons: Not every state has a PDMP. Information about manufacturer and product lot number are not explicitly tracked in PDMP databases today. PDMPs are not interoperable with EHRs or each other due to a variety of technical and legal issues. These issues will have to be addressed and resolved to handle biosimilar substitution. The lack of PDMP interstate interoperability is problematic in many metropolitan areas where patients may live in one state and get their prescriptions filled in another. As a result, a prescriber may not have complete information about a patient’s controlled substance prescriptions or substitutions. Plus, consulting the PDMP for controlled substances (and, when available, biosimilar substitution) lies outside the ePrescribing work flow, which would serve as a barrier to use. These changes and work-flow integration could take years and may not result in consistent information being available to prescribers because of state-to-state variations.

What’s our pick? My team at Point-of-Care Partners has been heavily involved in issues involving ePrescribing and biosimilars. While all four options described here to notify prescribers of a biosimilar substitution have some appeal, we believe RxFill is the best option. This transaction was designed to do what we need it to do, is part of the ePrescribing process, and the standards infrastructure has been expanded to accommodate biosimilars. It is available for use now by EHRs in all states.

The introduction of biosimilars in the US market requires significant changes to standards, EHRs, pharmacy systems and work flows. Now is the time to prepare.

Pooja is a Senior Consultant for Point-of-Care Partners. With more than 20 years’ experience in various healthcare services and health care IT companies, Pooja understands the perspectives of all stakeholders including PBMs, health plans, patients, physicians, ePrescribing and EMR vendors and hospitals/health systems.